Non-invasive Methods for Predicting Decompensation of Chronic Liver Disease

• Conditions: Chronic Liver Disease and Cirrhosis

• Registration Number: NCT06741904
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

Preliminary studies have suggested that non-invasive methods can not only be applied to CSPH but also to predict the risk of decompensation in cirrhosis. However, there is a lack of clinical evidence, and more research is needed to provide such evidence. Especially in China, where the etiology of cirrhosis is prevalent, there is a large population of patients with hepatitis B cirrhosis undergoing antiviral treatment. Exploring the value of non-invasive methods in predicting decompensation events in these patients can not only expand the clinical application of non-invasive methods but also provide effective non-invasive screening and management strategies for patients with cirrhosis at different risk levels.

Primary Objective: The main purpose of this study is to evaluate the predictive effectiveness of non-invasive methods (based on liver and spleen stiffness) for the occurrence of decompensation in chronic liver disease (CLD).

Secondary Objectives: To establish different predictive models for the occurrence of decompensation in CLD and to assess their predictive effectiveness as non-invasive methods for decompensation in CLD.

Approximately 2334 individuals will participate in this study at 17 different health care Setting.The study will last for 4 years, including 1 year of enrollment and 3 years of follow-up. Patients will be seen at 6-month intervals, and all examination results of patients as well as decompensation events, liver cancer, and death will be recorded.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-04
• Study First Submitted QC: 2024-12-15
• Last Update Submitted: 2024-12-15
• Study Start: 2024-12-16
• Study First Posted: 2024-12-19
• Last Update Posted: 2024-12-19
• Primary Completion: 2027-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 2334

Inclusion Criteria

• Aged over 18 years and under 80 years; ② Underlying chronic liver disease (etiology not specified);

  • Liver stiffness measurement (LSM) greater than 10 kPa or cirrhosis (diagnosed by imaging or histology);

    • Voluntarily signing an informed consent form.

Exclusion Criteria

• Have undergone orthotopic liver transplantation or Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedure;

  • History of liver cancer or other types of cancer diagnosed in the past or currently;

    • Acute or chronic portal vein thrombosis; ④ History of splenectomy or splenic embolization; ⑤ Currently in a decompensated stage (with complications such as variceal bleeding, moderate to severe ascites, hepatic encephalopathy, etc.).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Decompensation events	Patients were followed from the time of enrollment for a maximum of 3 years	Decompensated events included ascites, variceal bleeding, and hepatic encephalopathy

Trial Locations

Locations (1)

Nanfang Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangzhou, China